NOn-inVAsive Blood Pressure Monitoring in Intracranial Aneurysm Embolization
Recruiting now · Not applicable
Conditions studied: Cerebral Aneurysms, Intracranial Aneurysms, Coil Embolization, Hemodynamic Instability, Noninvasive Cardiac Monitoring
In brief
The goal of this clinical trial is to evaluate whether non-invasive continuous blood pressure monitoring (NVBP) using the ClearSight system can safely serve as an alternative to radial arterial catheterization for invasive arterial blood pressure monitoring (IABP) in patients undergoing coil embolization for unruptured intracranial aneurysms. The main questions it aims to answer are: * Does NVBP monitoring detect intraoperative hypotension and hypertension events with similar reliability compared to IABP? * Does NVBP monitoring reduce the need for invasive arterial catheterization without compromising patient safety or clinical outcomes? Researchers will compare patients assigned to NVBP monitoring with those receiving conventional IABP monitoring. Participants will: * Be randomly assigned to NVBP monitoring or standard IABP monitoring during coil embolization. * Receive continuous monitoring of cerebral oxygenation with near-infrared spectroscopy (rSO₂). * Undergo standard anesthesia induction, maintenance, and postoperative intensive care protocols. * Have their intraoperative hemodynamic events, vasopressor use, and postoperative outcomes recorded up to 30 days after the procedure.
Key facts
- Study ID
- NCT07246148
- Run by
- Korea University Anam Hospital
- People needed
- 50
- Starts
- 2026-01-01
- Expected to finish
- 2027-08-31
- Last updated by the study team
- 2026-04-09
Who can join
Age: 19 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult patients (≥19 and ≤80 years old) scheduled for elective coil embolization of unruptured intracranial aneurysms under general anesthesia.
- American Society of Anesthesiologists (ASA) physical status classification I-III.
You may not qualify if…
- Patients who do not provide informed consent.
- Patients unable to understand or follow study instructions due to physical or mental limitations.
- Patients in whom radial arterial catheterization is not feasible (e.g., peripheral vascular disease, skin disorders at the insertion site, absence of radial/ulnar artery, or orthopedic conditions of the upper extremity).
- Patients with peripheral vascular circulatory disorders.
- Patients with morbid obesity (BMI ≥ 40 kg/m²) [Eley et al., 2021].
- Patients who are hemodynamically unstable preoperatively or expected to be unstable during the perioperative period.
Where it is running
- Korea University Anam Hospital — Seoul, South Korea (enrolling)
Full record on ClinicalTrials.gov
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